SENTINEL CH. SpA - FDA 510(k) Cleared Devices

Cleared May 16, 2025

Cystatin C

K242585 · NDY

Chemistry · 259d

Cleared Dec 22, 2022

Lp(a) Ultra

K211058 · DFC

Chemistry · 622d

Cleared Dec 19, 2019

Albumin BCP

K193001 · CJW

Chemistry · 52d

Cleared Sep 27, 2018

CRP Vario

K173833 · NQD

Chemistry · 283d

Cleared Jul 28, 2014

ACE CALIBRATOR

K141728 · JIT

Chemistry · 32d

Cleared Aug 19, 2011

CKMB UDR ASSAY

K102706 · JHS

Chemistry · 333d

Cleared Jun 25, 2008

SENTINEL PLASMAPROTEINS CAL 3X

K081533 · JIX

Chemistry · 23d

Cleared Jun 19, 2008

MULTIGENT CREATININE (ENZYMATIC) ASSAY

K073634 · JFY

Chemistry · 176d